A variety of breast prostheses are known. These devices have been developed so that women who have undergone a surgical procedure in which they have had one or possible both breast removed, for example a mastectomy, may restore not only their cosmetic appearance after surgery, but their self-confidence as well. The use of breast prostheses has thus minimized the stigma that may have otherwise been attached to a woman's appearance after breast removal surgery.
One example of a prosthetic breast is disclosed in German Patent No. DE-AS 26 05 148. This prosthesis has a shell shaped component enclosed or enveloped by plastic films, and is made of a two-component silicone rubber material. A cured two-component silicone rubber material is used to form the shell of the prosthesis, which material corresponds in its weight to the approximate weight of natural breast tissue. The two-component silicone rubber material also simulates the actual conditions of a natural breast due to the soft, elastic responsiveness and mobility of the material. Additional breast prostheses of this type, which are intended for being placed in and supported by a brassiere, are disclosed in U.S. Pat. Nos. 4,172,298 and 4,249,975, respectively.
In order to assure the most natural appearance of the breast prosthesis when inserted in the brassiere, a breast prostheses of the type described above may be provided with a first body portion forming the convex exterior side of the prosthesis, this portion being made of a soft set material. In addition, a second and flat shell shaped body portion forms the back or inner side of the prosthesis, which second body portion is made of a slightly harder set two-component silicone rubber material. The result of this design is that the elastically soft material of the first body portion, which due to its weight tends to sink slightly along the convex external side thereof, is supported by the rear or flat shell body portion made of the stiffer material. The disadvantage of this type of prosthesis, however, is due to the fact that as the inner shell is fabricated of a relatively harder or stiffer two-component silicone rubber material, the inner shell will press on the sensitive scar tissue area(s) of the patient's external chest wall. Additionally, the inner shell also does not adjust, i.e., it does not conform, about the scar tissue area(s) in order to protect or cushion those tissues.
The problem persists in that many of the known types of external breast prostheses have not been made adaptable to fit any irregularities that may be present in the chest wall of the mastectomy patient, particularly as modern surgical techniques remove less tissue and leave more irregular chest wall contours. Although matching a patient's chest wall contours has been accomplished by the custom-molding of a prosthesis for each patient, a need exists for a prosthesis that has desirable appearance and touch characteristics, which can adapt to the chest wall contours of a wide variety of women, and can also be made available in a cost-effective manner.
One attempt to satisfy this need is disclosed in U.S. Pat. No. 4,950,291 to Mulligan, the provisions of which are incorporated herein by this reference. The '291 patent discloses a 2-layer breast prosthesis comprised of an outer layer or shell filled with a relatively firm elastomeric silicone gel, and an inner layer of an extremely soft and flowable cross-linked silicone gel. The softer, flowable gel will conform to the chest wall with a minimum of applied force, but does not possess self-molding characteristics such that, for example, the flowable gel does not hold its shape when the prosthesis is removed. Also, due to the fact the inner gel readily flows, the gel can “pool” at times in and along the bottom of the prosthesis due to the influence of gravity, which in turn may lead to patient discomfort and generally does not offer any additional support to the fit and security of the prosthesis. Furthermore, the soft gel-like material disclosed in the '291 patent is of the same density as the outer gel, and can therefore result in a final product, which may be heavier than a comparable single layer prosthesis.
What is needed, but seemingly unavailable in the art, is an improved breast prosthesis that will have the desired outward cosmetic appearance, shape, and feel of a woman's breast, yet will be adaptable to the chest wall of the wearer by forming to the profile thereof. What is also needed is such an improved breast prosthesis which will be lighter than the known prosthetic devices for greater patient comfort during prolonged wear, and which may also be light enough that it will be self-supporting on the chest wall of the wearer. Additionally, there is a need for an improved two-layer breast prosthesis having a relatively firm outer shell component with a relatively soft and compliant inner shell component that will not settle as the prosthesis is worn by a patient.